Key Achievements 2010 - European Commission - Europa EU

Key Achievements 2010

Public Health and Risk Assessment Directorate

The information contained in this publication does not necessarily reflect the opinion or the position of the European Commission. Neither the European Commission nor any person acting on its behalf is responsible for any use that might be made of the following information.

© European Communities, 2011 Reproduction is authorised provided the source is acknowledged.

Foreword

Top facts 2010 1. PATIENTS’ RIGHTS – in cross border health care

2010 was a really successful year for our efforts to bring Europe even closer to patients. After over two years of intense negotiations, the European Parliament and the Council of Ministers reached a political agreement paving the way for adoption, in early 2011, of the Directive on patients’ rights in cross-border healthcare. EU citizens will thus have clarity regarding their rights to access safe and good quality treatment in other EU Member States and to be reimbursed for it. Also in 2010, at the beginning of his second mandate, President Barroso decided to transfer responsibility for pharmaceutical products from DG Enterprise and Industry to DG Health & Consumers. As the relevant unit joined my Public Health and Risk Assessment Directorate, this means that we are now better equipped to lead a consistent and coherent approach to public health policy and, more specifically, to ensure the protection of patients and safety of medicines throughout the EU. An assessment of the EU response to 2009 pandemic H1N1 led to agreement on faster registration procedure and quicker information about vaccines, developing procedures for their joint procurement and better joint management of the pandemic. My services are currently working on a Health Security Initiative to address all these issues. In 2010, we embarked upon global challenges, such as Commission proposal to enhance the EU’s role in global health. The objective is to engage all stakeholders and global partners to improve health at global level. These and many other achievements of Public Health and Risk Assessment Directorate are described in this brochure. I’d personally like to thank all colleagues for their contributions to these achievements.

A milestone for all EU patients: a political agreement was achieved by the European Parliament and Council of Ministers in December 2010 leading to adoption of a new Directive on patients’ rights in cross-border health care. This Directive will provide clear and coherent set of rules on the reimbursement of crossborder health care, facilitate the recognition of prescriptions from other Member States, help patients requiring specialised treatment, and facilitate exchange information on quality and safety standards of health care. More on page 18

2. PHARMACEUTICALS – responsibility taken over by DG SANCO and new legislation In February 2010, the responsibility for pharmaceuticals, previously under the remit of the Directorate General of Industry and Enterprise, has been transferred to DG SANCO. The new legislation on pharmacovigilance in December 2010 and the work carried out for a new Directive on falsified medicines are milestones in EU legislation on pharmaceuticals. The Union has sent a clear message to European citizens with this comprehensive legal framework which seeks to ensure the safety, efficacy and quality of medicines put onto the market by economic operators. More on page 23

3. H1N1 – better management of future threats The EU response to the 2009 pandemic was assessed during 2010 leading to profound evaluation about how the EU and the Member States responded to H1N1. An agreement was reached on the revision of the Pandemic Readiness Plan of the EU, specifically, a fast registration procedure and quicker information about vaccines, joint procurement of vaccines and antiviral medication and better procedures on the joint management of the pandemic. More on page 27

4. Global Health – new EU policy framework

Andrzej Ryś Director - Public Health and Risk Assessment

DG SANCO has been a key actor in setting up a new EU policy framework to guide actions on global health. Four main approaches to improving global health were outlined: more democratic and coordinated global governance; promotion of universal coverage and access to health services for all; better coherence between EU internal and external policies relating to health and increase knowledge and access to new treatments, A global health policy forum was set up bringing together Commission services, EU Member States, international organisations, NGOs and industry to discuss on a monthly basis topics relevant to global health. More on page 54

5. EU Health Journalism Prize – a growing network As part of the Europe for Patients campaign, the second edition of the EU Journalism Prize was highly successful with 745 articles submitted (60% more than in 2009) from 438 journalists (nearly 50% more) from all over EU. In November 2010, outstanding journalists from Italy, Czech Republic and Denmark were awarded first, second and third prize for their articles on patient safety and organ donation. The prize allowed to establish an informal network of more than 700 national journalists and editors interested in EU health issues. More on page 17

Steering EU Public Health

Index Steering EU public Health

p. 7

March 2010 Health.

Europe for Patients

p. 15

May 2010 -

Adoption of the Commission Communication on Global

Adoption of the Council conclusion on Global Health.

June 2010 Pharmaceuticals

p. 23

Adoption of the Council Conclusions on Equity and Health in All Policies: Solidarity in Health.

July 2010 Preventing threats to health minimising risks

Risk assessment

p. 26

p. 29

Adoption of Directive 2010/53/EU on the quality and safety of human organs by the Council and Parliament in first reading.

September 2010 -

Adoption of Council conclusions of 13 September 2010 on “Lessons learned from the A/H1N1 pandemic – Health Security in the European Union”.

November 2010 - Adoption of Commission Staff Working Document on Fostering good health

p. 34

lessons learnt from the H1N1 pandemic and on health security in the European Union.

December 2010 -

tive on pharmacovigilance.

Health information and communication

p. 42

Participation Mechanisms

p. 51

International cooperation

p. 53

Adoption of European Parliament and Council Direc-

December 2010 -

The European Parliament and Council of Ministers achieved an agreement on the Directive on patients’ rights in cross-border healthcare.


Health Strategy implementation

The Health Strategy: “Together for Health : A Stratgic Approach for the EU 2008-2013” was published in 2007 and aims to provide an overarching strategic framework spanning core issues in health as well as health in all policies and global issues.

Health Working Party at Senior level The Senior level group, one of the two coordination mechanisms for the EU health strategy met twice in 2010 under the Spanish and Belgian Presidencies. The special topics for discussion were quality in healthcare (Spain) and global health (Belgium). The Belgian Presidency also initiated an exchange of views on the working of the Senior Level group. This will be followed up in 2011 with the mid-term evaluation of the EU health strategy.

Structural funds and Co-operation with regions on health


European regions and cities play an important role in delivering health to citizens. Because of this, SANCO felt that the implementation of the objectives of the EU Health Strategy would benefit from more structured co-operation with regions on health issues. A SANCO/Committee of the Regions Technical Platform for co-operation with regions on health issues was set up in June 2010. It aims to: • Involve regions and local authorities early on in the definition of the EU health policy and initiatives; • Facilitate an exchange of good practice and • Support the implementation of the EU Health Strategy. Two meetings of the Technical Platform took place on investment in health through the Structural Funds and regional health promotion strategies. In addition to the Technical Platform, an Intergroup on Health was set up at the end of 2010. It is comprised of Committee of the Regions cross-party members interested in health issues. As a follow-up on these initiatives, the Committee of the Regions adopted an owninitiative report on the Role of local and regional authorities in the implementation of the EU Health Strategy (the ‘Banaszak Report’), which was welcomed personally by Commissioner Dalli in a speech delivered to the Committee of the Regions in plenary in December 2010.

Steering EU Public Health Healthy Ageing Workshops As part of the implementation of the EU health strategy, it was felt that more information on the scope and range of actions to encourage healthy ageing at EU level was needed. At the same time, in June 2010, the Europe 2020 strategy highlighted ageing as a societal challenge. Three workshops on different aspects of healthy ageing were organised in order to bring together experts from wide ranging backgrounds including academia, non-governmental organisations, professional bodies, national and regional institutes and research bodies. Each workshop focussed on a specific theme: • adapting health systems to the future demographic, • meeting the health needs of older people through innovations and technology, • keeping older consumers active. The participatory approach was used to inspire people to share success stories, identify new potential actions and explore how to move these actions forward. The actions were grouped into three areas: 1. actions to keep people active and able 2. preparing society for healthy ageing 3. increasing participation and reducing isolation The results of the 3 workshops’ will feed into: • the pilot innovation partnership on Healthy & Active Ageing, under The Innovation Union, one of the Europe2020 Flagship Initiatives • the 2012 as European Year for Active Ageing • the development of EU Health Strategy and EU Consumer Policy Strategy. A short reflection paper on the outcomes of the workshops is available at: http://ec.europa.eu/health/ageing/docs/ev_20101011_reflections_en.pdf Detailed reports of each workshop are available at: http://ec.europa.eu/health/ageing/policy/index_en.htm


Health Programme

2008-2013

Together for Health

Health Programme implementation The EU is required by its founding treaty to ensure that human health is protected as part of all its policies, and to work with the EU countries to improve public health, prevent human illness and eliminate sources of danger to physical and mental health. The Second Programme of Community Action in the Field of Health came into force on 1 January 2008 and lasts for six years until 2013. Its total budget accounts for 321.5 million euros, used to finance projects and other actions which contribute to increased solidarity and prosperity in the European Union by protecting and promoting human health and safety, according to the EU treaty and the adopted legislation. The Programme has three main objectives: 1) improve citizens’ health security; 2) promote health and reduce health inequalities and 3) generate and disseminate health information and knowledge. Countries participating in the Programme are all the EU Member States, Norway, Iceland, Liechtenstein and Croatia The Health Programme is managed by the Commission, Directorate for Health and Risk assessment and the Executive Agency for Health and Consumers. In 2010, the budget was 47,1 million euros, which financed 17 projects (ca. € 13,4 mio), 8 conferences (ca. € 800,000), 7 operating grants (ca. € 2 mio), 9 joint actions (ca. € 10,6 mio), tenders (ca. € 15,2mio), cooperation with international organisations (ca. € 3,5 mio) and other actions. In 2009, the Commission launched the evaluations of both the Public Health Programme 2003-2008 and the Executive Agency for Health and Consumers (EAHC). The results of the evaluations are expected in 2011.

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per participating country) and was carried out in Prague, Bratislava, Ljubljana, Barcelona, Verona and Bucharest. The project identified key issues affecting MSM communities, their risks and vulnerability to HIV/AIDS and their needs for HIV/AIDS prevention treatment and care. Gay NGOs were directly involved in the project. Acute lack of awareness of HIV positive serostatus meant that 56% of HIV positive people were not aware of their HIV status (70% in Bucharest and Ljubljana and only 50% in Barcelona). A second project Sialon II was approved for funding under the 2008-2013 Public Health Programme (workplan 2010). Like the original Sialon project, Sialon II aims to carry out and promote combined and targeted prevention complemented by a meaningful surveillance among MSM. In addition, the project aims to create a network of institutions working with the ECDC to implement new tools for STI surveillance and with DGSANCO, in support of comprehensive, integrated HIV/STI prevention strategies. Thanks to a collaboration with UNAIDS and WHO, the geographical coverage of Sialon II will be extended with the project being implemented in both the EU (Italy, Belgium, Bulgaria, Germany, Slovak Republic, Spain, Lithuania, Poland, Sweden, Slovenia, Romania) and neighboring countries (Russia, Armenia, Belarus, Moldova). The project will run for 36 months and will have a budget of approximately €1,500,000. More information at: http://www.sialon.eu/en/documents/

The main actions co-funded under the second Community Health Programme were as follows:

Health Technology Assessment Joint Action A Joint Action on Health Technology Assessment (HTA) was launched at the beginning of 2010. It is co-financed by the European Commission, is composed of 23 Member States, Croatia and Norway, and will last for three years. Building on the previous EUnetHTA project, central aims of the Joint Action are: •To test a shared methodology to make joint European HTA reports on selected health technologies; and • To develop tools for interaction between European HTA agencies. The Joint Action will provide valuable input into the question of how regular European cooperation on HTA could be set up in the longer term.

Best projects 1. SIALON I and II: Obtaining reliable data on HIV/AIDS in vulnerable groups in Southern and Eastern Europe This project was funded under the 2003-2008 Public Health Programme (work plan 2007). The project ran for a duration of 24 months with a budget of € 714,000 (EU contribution: € 397 353.00) and concluded in April 2010. Lead: Regione del Veneto, Italy (participated 6 EU Member States and future MS) The objectives were to obtain reliable and valid information on HIV and syphilis prevalence, to study sexual behaviour risk patterns and identify the determinants of voluntary counseling and testing access among Men who have Sex with Men (MSM) - a vulnerable group with a higher risk of HIV infection. Previous data indicated that HIV infection rates were rising in Western European countries while there was less information regarding southern and Eastern Europe. SIALON used a noninvasive outreach testing method based on oral fluid samples. 2.407 subjects from Czech Republic, Slovakia, Slovenia, Spain, Italy and Romania were enrolled in the study (circa 400

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2. SHIPSAN and SHIPSAN TRAINET: Improving communicable diseases surveillance on ships and ferries These projects were funded under the 2003-2008 Public Health Programme (work plan 2005 and 2007). The SHIPSAN project ran for a duration of 24 months and ended in December 2008 with a budget of € 598.840 (EU contribution € 359 309), SHIPSAN TRAINET runs for 30 months (November 2008 – May 2011) with a budget of € 1,500,00 (EU contribution: € 799 984). Lead SHIPSAN: University of Thessaly National School of Public Health (Ethniki Scholi Dimosias Ygeias Eidikos Logariasmos), Greece, participation of 14 EU Member States Lead SHIPSAN TRAINET: University of Thessaly National School of Public Health (Ethniki Scholi Dimosias Ygeias Eidikos Logariasmos), Greece, participation of 18 EU Member States and 4 Euromed countries: Jordan, Lebanon, Israel, Turkey The European Ship Sanitation (SHIPSAN) project and the EU Ship Sanitation Training Network (SHIPSAN TRAINET) contribute to the prevention of trans-national transmission of diseases by improving the disease surveillance on ships, developing means to report and communicate the information, and implementing the hygiene standards on ships. SHIPSAN established a robust network between transport stakeholders and the public health authorities responsible for risk management including WHO, integrating its communication platform with the current EU alert system for communicable diseases. More information at: http://www.eu-shipsan.gr/ 3. EPISOUTH and Episouth plus: Creating a framework for collaboration on epidemiological issues between the EU, Balkan and Southern Mediterranean countries These projects were funded under the 2003-2008 Public Health Programme (work plan 2005 and 2009). The EPISOUTH ran for a duration of 36 months with a budget of € 2.308.722,26 (EU contribution: 1 719 032.68) and was concluded in June 2010, the EPISOUTH+ runs for a duration of 30 months with a budget of € 4.687.888,14 (EU contribution € 900 000). Lead: Istituto superiore di sanita, Italy (participated 9 EU and 18 non-EU countries) The ‘Network for communicable disease control in southern Europe and Mediterranean countries’ (EPISOUTH) project has developed a network to foster the collaboration on epidemiological

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Steering EU Public Health issues and to improve communicable diseases surveillance, detection, alert and training across 27countries (9 EU and 18 non-EU) bordering the Mediterranean sea, including the Balkans. The EPISOUTH Plus project continue to work in the same direction but tackle additional challenges such as generic preparedness issues and the establishment of a network of Mediterranean Regional Reference Laboratories that support the detection and alert of emerging communicable diseases in the area. More information at: http://www.episouth.org/ 4. PHBLM: Increasing public health safety alongside the new Eastern border of enlarged EU This project was funded under the 2003-2008 Public Health Programme (work plan 2006). The project ran for a duration of 36 months with a budget of € 782.726,53 (EU contribution: € 469.408,38) and concluded in June 2010. Lead: International Organisation for Migration with 3 MS To fight crossborder threats, the EU co-funded the International Organisation for Migration (IOM) through the project ‘Increasing public health safety alongside the new Eastern European border line’ (PHBLM) . The project included four main components: situational analysis of the current public health conditions and border management procedures; development and regional testing of a training module; development of minimum public health standards and a proposal for structural changes; and dissemination of the project results. The project has developed guidelines for identification and management of risks public health management and detention procedures and recommendation for structural changes to health/public health services in the targeted border sectors. Furthermore, training materials on migration aimed at health professionals and border guard staff have been developed and tested.

Europe for Patients

More information at: http://www.belgium.iom.int

http://ec.europa.eu/eahc/health/health.html

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Europe for Patients The Europe for Patients campaign, launched in September 2008, continued throughout 2010. The Commission adopted new initiatives on Cross-border healthcare, pharmacovigilance, quality and safety of human organs, and implemented other patient and healthcare related initiatives that had been adopted in previous years. The Europe for Patients campaign highlights 12 health policy initiatives, all bound by a common goal: better healthcare for all in Europe. The initiatives and actions address cross-border healthcare, patient safety, rare diseases, organ donation and transplantation, cancer, health workforce, flu and childhood vaccination, Alzheimer’s diseases and other dementias, mental health and prudent antibiotic use and pharmaceuticals. The aim of the campaign is to provide a single entry-point to the often complex world of EU healthcare policies and actions. 2010 saw also the revamping of the web-site where all information related to the campaign’s policies can be found in 22 languages. More at http://ec.europa.eu/health-eu/europe_for_patients/index_en.htm

Europe for Patients

Second edition of the EU Health Prize for Journalists The second EU Health Prize for Journalists was launched on 25 March 2010. 438 journalists from the 27 EU Member States participated, submitting a total of 745 articles in all official EU languages. The competition was very successful. 44% more journalists participated than the previous edition and 60% more articles were submitted. There was an impressive media coverage in the EU. The aim of this prize is to reward the work of European journalists who have contributed in a significant way to helping citizens understand health issues covered by the Europe for Patients campaign. Cash prizes were given for the amounts of 5000 euros for first place, 3000 euros for second place and 2000 euros for third place. The winners of this edition are Gianluca Ferraris and Ilaria Molinari with ‘Stealing Hope’ (Panorama, Italy). This article deals with a frightening, modern-day phenomenon. It exposes a scandal that is worth talking about. Second Prize - Lucie Hášová Truhelková: ‘Love Dwells in the Kidney’ (MF Plus, Czech Republic) a thorough and revealing article that highlights an important, difficult and heart-rending issue: organ donation and transplantation. Third Prize – Kasper Krogh, Morten Crone, Line Holm Nielsen and Jesper Woldenhof: ‘The Great Failure’ (Berlingske Tidende, Denmark). This important article shines a spotlight on the consequences of a failure in the healthcare system. It illustrates the importance of public policy. The award ceremony was held in Brussels on 30 November 2010 in the presence of national winners, national editors, jury members and Commission representatives and was hosted by Commissioner John Dalli and DG Paola Testori Coggi who awarded the prizes. The second edition lead to the establishment of an informal network of more than 700 national journalists and editors interested in EU health issues who can assist the Commission in raising awareness and promoting activities and messages about health issues widely in the EU. A Facebook page was specifically created to stimulate discussion and to share documents and news. Read all the articles at http://ec.europa.eu/health-eu/journalist_prize/2010/index_en.htm http://www.facebook.com/pages/EU-Health-Prize-for-Journalists/109464325763850 Journalist Prize 2010, Brussels, 30th November 2010

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Europe for Patients

Europe for Patients

Patient Safety and Quality of Care A reflection process with Member States and EU stakeholders on possible future EU actions in the field of quality of healthcare took place during 2010. The following areas for future action were identified:

Cross-border Healthcare Directive The European Parliament and Council of Ministers achieved an agreement on the Directive on patients’ rights in cross-border healthcare in December 2010.

• To collect knowledge about quality and safety systems in place in Member States; • To explore the possibility of evaluating quality assurance systems - the extent to which they embody a patient-centred approach, as well as analyses of factors contributing to the success and/or failure of the strategy; • To share best practices among Member States (at national, regional or local level); disseminating information about the systems that have been created, implemented and continuously evaluated and improved; • To reflect on principles of good quality healthcare, with a focus on involvement of patients in decisions about treatment, capturing patient feedback as well as involvement of patients’ organisations in policy making.

This followed over two years of intense negotiations:

In 2010, a Eurobarometer survey collected views from EU citizens about the safety and quality of healthcare received in their respective country. According to the survey, half of respondents were afraid they could be harmed by both hospital and non-hospital care. A quarter said they, or a member or their family, was harmed while receiving healthcare.

June 2010: The Spanish Presidency succeeded in reaching a political agreement at the EPSCO Council; September 2010: Second reading negotiations started with the European Parliament;

More informationis available at: http://ec.europa.eu/health/patient_safety/eurobarometers/index_en.htm

November - December 2010: Three trilogue meetings took place between the European Parliament, the Belgian Presidency and the European Commission; December 2010: Negotiations were successfully concluded by the Parliament and Council of Ministers. This Directive will pave the way for EU patients to have clarification on their rights to access safe and good quality treatment across EU borders, and be reimbursed for it. In addition to providing a clear and coherent set of rules on the reimbursement of cross-border healthcare, the Directive will benefit patients in several other ways. For example: • It will make it easier for national health authorities to work closer together and exchange information on quality and safety standards of healthcare; • It will help patients requiring specialised treatment, such as those who are need diagnosis or treatment for a rare disease. • Member States are required to set up at least one national contact point which would provide necessary information to patients.

Health Workforce As a follow up to the 2008 green paper on the European workforce for health, a series of stakeholder dialogues took place on current needs of the health workforce in the EU and on possible ways to address the shortage of health workers. The following topics were discussed: • • • •

Assessing the needs of the health workforce of the future; Creating conditions for adapting skills to new needs and lifelong learning; Creating an attractive and supportive working environment for health professionals; Ensuring the best quality and safety of care delivered by health professionals.

The outcome of the policy dialogues was discussed by the Belgian Presidency at a Ministerial Conference in September 2010 on investing in the health workforce of the future.

• It supports the development of “European Reference Networks”. This will help health experts across Europe to share best practices on healthcare and provide standards of excellence.

The following specific issues relating to the health workforce were formally recognised at EU level: • In a Commission Communication “New Skills and Jobs” as part of the Europe 2020 Strategy; • In the Council Conclusions of December 2010, “Investing in Europe’s health workforce of tomorrow: Scope for innovation and collaboration”.

• The European Commission will also set up networks to enhance EU co-operation on health technology assessment and eHealth.

An Action Plan on the health workforce will be developed in 2011 by the European Commission together with Member States.

Member States have 30 months to transpose these measures into national legislation after the Council of Ministers formally adopted this Directive during the course of the Hungarian Presidency.

A co-ordinated EU approach should help ensure that there remain an adequate number of welltrained and motivated health workers in the EU. This is a condition to ensuring that necessary care is provided to all citizens.

More information at: http://ec.europa.eu/health/cross_border_care/policy/index_en.htm

More information is available at: http://ec.europa.eu/health/workforce/green_paper/index_en.htm

• The new legislation will help facilitate the recognition of cross-border prescriptions.

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Europe for Patients

Europe for Patients

Organ Donation and Transplantation

Mental Health

In July 2010, Directive 2010/53/EU on the quality and safety of human organs was adopted by the Council and Parliament in first reading. On 8 December 2008, a Communication from the Commission was also adopted regarding the Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States. In the course of 2010 progress was made on several of these actions: TRANSPLANTATION IN EUROPE organu

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More information: http://ec.europa.eu/health/mental_health/policy/index_en.htm

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• Technical Working Group on Living Donation Living donation is a potential alternative to increasing the number of available organs, however it often raises several questions on psychological aspects, legality and ethics. Two projects (EULID, ELIPSY) on living donation have already been funded under the Health Programme. This technical working group will better disseminate existing results as well as help Member States establish a framework within which living donation can be developed, based on experiences of other Member States.

In line with the overall purpose of the European Pact for Mental Health and Well-being, the conferences enabled EU-Member States, relevant professional and civil society actors to exchange and improve cooperation on challenges and opportunities in mental health and wellbeing.

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• Manual on Transplant Donor Coordinators The technical working group on deceased donation drafted a manual to help Member States integrate and improve the role of transplant coordinators at national level with the aim to improve the donation and transplantation process. The manual will be distributed to the Member States.

• Mental Health and Well-being in Older People- Making it Happen (28-29 June 2010) Conference organised by the European Commission and the Spanish Government • Promoting Social Inclusion and Combating Stigma for better Mental Health and Well-being (8 -10 November Lisbon, Portugal)

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• Indicators Exercise The aim of this exercise is to cover all aspects of donation and transplantation, to enable comparisons between countries, progress in monitoring, and to identify opportunities for improvement and sharing good practices.

The ‘European Pact for Mental Health and Well-being’ launched in 2008, was further implemented in 2010 by means of two conferences:

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In April 2010, the Public Health and Risk Assessment Directorate published 2 reports: the 2010 Eurobarometer survey on AMR(antimicrobial resistance) and the 2nd report on the implementation of the Council recommendation on the prudent use of antimicrobial agents. These reports provided information on progress made by the Member States in tackling AMR as well as on citizens’ perception of AMR-related threats and the importance using antimicrobial agents prudently. The conclusions were communicated to the national AMR experts to support them in the implementation on their national initiatives. The conclusions were of particular value for the 3rd European Antibiotics Awareness Day and the preparation of a new SANCO Strategy against AMR. This contributes to better communication and awareness of a public health threat that results in 25,000 patients deaths and in 1.5Bn€ healthcare costs and productivity losses in the EU every year. More information at http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10 412&format=HTML&aged=0 &language=EN&guiLanguage=en

• Workshop with Journalists in November The objective of this workshop was to inform and sensitize EU journalists about organ donation and transplantation and provide them with all available tools so as to access the correct information for their coverage of this issue. The workshop was a great success and a large percentage of participants have already written articles.

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Europe for Patients

Launch of the Transatlantic Task Force on AMR Following the November 2009 EU and US Summit’s declaration calling upon the EU and US administrations to strengthen transatlantic cooperation, in 2010 the two administrations agreed to set up a transatlantic task force on AMR. This taskforce involves public health and veterinary experts from the US health authorities, the EU and national administrations aims to identify and recommend areas for future cooperation in both the human and the veterinary medicine sector. Infection control and strategies to improve the pipeline of new antimicrobial agents are other aims. These recommendations are based on the conclusions of working groups involving EU and US experts and public consultations launched in the EU and US in 2010. They will be submitted at the next EU/US Summit in 2011 for approval and decision on the follow-up. More at http://ecdc.europa.eu/en/activities/diseaseprogrammes/tatfar/pages/index.aspx

Pharmaceuticals

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Pharmaceuticals

Pharmaceuticals In February 2010, following a reorganization of the Commission’s portfolios, the unit responsible for Pharmaceutical issues, previously in DG ENTR, joined SANCO/Directorate C.

A new pharmacovigilance legislation Once a medicinal product has been authorized in the Community and placed on the market, its safety continues to be monitored throughout its entire lifespan. This is done through the EU system of pharmacovigilance. In December 2010, the European Parliament and the Council adopted the new legislation on pharmacovigilance put forward by the Commission on 10 December 2008. The new legislation was published in the Official Journal of the EU on 30 December 2010 and will enter into force in 2012.

Why did we need to improve the EU pharmacovigilance system? Pharmacovigilance is a key public health function and there is a need to strive to ensure it is optimally effective. Although evolving over time, the current system of pharmacovigilance in the EU has been established for a number of years and it was an appropriate time to strengthen and rationalise it. There is a need to ensure that our pharmacovigilance systems are robust but also transparent, and to consider the appropriate level of involvement in the system of different stakeholders, including health care professionals and patients.

How will the new Pharmacovigilance legislation ensure greater patient safety? The new rules on Pharmacovigilance ensure better prevention, detection and assessment of adverse reactions to medicines. It will: • Set out clear tasks and responsibilities for all parties involved in the EU pharmacovigilance system (Member States, marketing authorization holders and the European Medicines Agency). • Improve decision-making procedures and use resources more efficiently. • Manage risk proactively and proportionately, avoiding unnecessary administrative burden and providing for a stronger link between safety assessments and regulatory action. • Involve stakeholders in pharmacovigilance, including through direct patient reporting of suspected adverse drug reactions directly to the competent authorities. • Strengthen communication and transparency on medicine safety for example through the setting up of web portals by the national authorities which are linked to the European medicines web-portal (managed by the European Medicines Agency) thus enabling patients and healthcare professionals to access important information on medicines. • Strengthen companies’ pharmacovigilance systems. • Ensure the proactive and proportionate collection of high quality data. More information at : http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm

Simpler rules for the authorisation of Traditional Herbal Medicines The Herbal Directive adopted on 31 March 2004 introduced a simplified registration procedure for traditional herbal medicines with a transitional period of seven years for those products that were already on the market on the date of entry into force of the Directive. The simplified registration procedure aims to safeguard public health and remove differences and uncertainties about the status of traditional herbal medicinal products that existed in the past in the Member States. It also aims to facilitate the free movement of such products by introducing harmonized rules in this area. To further simplify the authorisation of traditional herbal medicines, in 2010 the Commission included a new entry in the EU list for traditional herbal preparation based on the opinion of the Committee for Herbal Medicinal Poducts. More information at: http://ec.europa.eu/health/human-use/herbal-medicines/index_en.htm

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Preventing threats to health minimising risks

Addressing the challenges of cross border health threats During 2010, the Commission continued to work on strengthening the prevention, preparedness, surveillance and coordination of response to health threats. The networks for the epidemiological surveillance and control of communicable diseases as well as the EU Health Security Committee (including the consolidation of the Health Security Communicators’ network) have been of pivotal importance to share information crucial for public health management of acute events. Examples of such events are outbreaks of communicable diseases , the Eyjafjallajokull Volcano eruption in Iceland andr the forest fires in Russia. In addition to these activities a number of initiatives co-funded by the Commission and implemented by the EAHC have been instrumental in aligning the EU response to health threats with the new International Health Regulations whose first deadline for implementation has been fixed for 2012. A number of initiatives have been remarkably successful in streamlining the coordination of response to health threats in this way.

Pandemic preparedness

Preventing threats to health minimising risks

With Pandemic (H1N1) influenza activity returning to the normal level seen for seasonal influenza in most countries, 2010 was an opportunity to reflect upon the EU response to the 2009 pandemic and learn lessons. The Commission financed a workshop on Business Continuity Planning (BCP) and multisectoral issues during a pandemic which was held on 29-30 April 2010. The workshop was organised by the Spanish Presidency with the aim to share experiences and best practices of Member States and the Commission to facilitate cooperation within the EU. Experts agreed on the need to better understand and map cross-sector dependencies. The Commission assisted the Belgian Presidency in organizing a conference on Health security: lessons learned from the A(H1N1) pandemic in 2009 – better management of future health threats. This conference was held in Brussels on 1-2 July 2010. It provided an opportunity to discuss the lessons learned by the Member States, the European Commission and health agencies regarding the fight against the H1N1 pandemic. The aim was to examine the difficulties that were encountered, how they were dealt with, and the lessons learned. The debate focussed on four topics: surveillance during the pandemic, multisectoral aspects, medical countermeasures (antivirals and vaccines) and communication. More information: http://www.eutrio.be/pressrelease/conference-lessons-learned-influenza-pandemicah1n12009 The conclusions of the conference were presented to the informal meeting of the EU Health Ministers for their discussion on 6 July 2010. Ministers agreed on the revision of the Pandemic Readiness Plan of the EU. Specifically, a fast registration procedure and quicker information about vaccines, developing procedures for common acquisition of vaccines and antivirals and better procedures on the joint management of the pandemic. More information: http://www.eutrio.be/pressrelease/informal-meeting-epsco-council-regarding-public-health

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Preventing threats to health minimising risks The Commission and the Member States evaluated their response to the pandemic. The focus is on reviewing pandemic response plans and interoperability between national plans, business continuity plans, robustness and efficiency of communications systems, effectiveness of communications, coordination of public health and control measures, response to mediaquests and availability and use of vaccines and anti-viral medicines. A second evaluation reviewed pandemic influenza vaccination strategies and provided a self assessment toolkit to support evaluation of national responses to the pandemic and joint procurement of vaccines, stockpiling and vaccine safety. Both reports became available in 2010. More information: http://ec.europa.eu/health/communicable_diseases/docs/assessment_response_en.pdf http://ec.europa.eu/health/communicable_diseases/docs/assessment_vaccine_en.pdf On 18 November 2010 the Commission issued a Staff Working Document on lessons learnt from the H1N1 pandemic and on health security in the European Union. The paper sets out ongoing and future work related to joint procurement of vaccines and antiviral medication, guidance on influenza pandemic preparedness and response planning and an initiative on prevention and control of other serious cross border threats to health. These three elements were also addressed in the Council conclusions of 13 September 2010 on “Lessons learned from the A/ H1N1 pandemic – Health Security in the European Union”. More information: http://ec.europa.eu/health/preparedness_response/docs/commission_staff_lessonsh1n1_ en.pdf http://register.consilium.europa.eu/pdf/en/10/st12/st12665.en10.pdf

Other Communicable Diseases and substance of human Origin

Risk assessment

Communicable diseases have direct implications for the safety of blood and tissues/cells as some of these diseases may be transmitted from donors of blood and tissues/cells to patients. Surveillance and vigilance of communicable diseases is therefore a standing agenda point at the bi-annual meetings of the national Competent Authorities for blood and tissues/cells, where Member States exchange information, experience and expertise in ensuring quality and safety of tissues/cells and blood, in line with the EU legislation in the field. During 2010, there was one of the biggest outbreaks of West Nile Virus infections in the EU as well as an outbreak of Q-fever in the Netherlands – both diseases may be transmitted through blood and tissues/cells. To ensure swift response to these outbreaks, the Commission liaised with the ECDC and the responsible national authorities in the affected countries, to collect the relevant information on the magnitude of the outbreak and safety measures taken. This information was then communicated to all relevant national authorities in the EU. A number of Member States reported to have implemented safety measures based on the information communicated by the Commission. The Commission together with a number of Member States, is developing a European preparedness plan for blood safety and West Nile Virus. More information: http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm

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Risk assessment

Risk assessment

Synthetic Biology Workshop Technological innovation is at the heart of the European Union’s efforts to provide better quality of life to its citizens and to increase the competitiveness of the European Industry. Yet, the results of technological innovation raise questions about their potential risk to human health and the environment. Synthetic biology, an emerging field of science that aims at creating new or redesigning existing biological systems on the basis of engineering principles is not an exception. In order to proactively address any health and environment related issues, the European Commission organised on 18 and 19 March 2010 in Brussels a workshop on “Synthetic Biology: From Science to Governance”. This workshop brought together leading scientists and experts on ethical, social and legal issues. The first day of the workshop focussed on the major technological developments in a wide range of activities and applications arising from synthetic biology. Presentations included updates on recent developments in health, environment and energy. The day finished with a debate on the definition and scope of the term “synthetic biology”, the current state of the science, as well as expected future developments and applications from research in this field. On the second day the main challenges for governance that might arise from synthetic biology applications were discussed. A special session focussed on the possible governance needs, as well as on setting the basis for concrete governance approaches. Presentations touched upon related issues, including intellectual property rights, ethics, and public perception. The workshop finished with a roundtable debate on the main governance approaches and challenges for/from synthetic biology. You may read more about this event on the following webpage: http://ec.europa.eu/health/dialogue_collaboration/events/ev_20100318_en.htm

EU Nanoconversation with Stakeholders on Textiles On June 15, DG SANCO organised in Brussels a “nanoconversation”. The idea to hold “nanoconversations” came out of the 3rd Nano Safety for Success Dialogue conference in November 2009 as a tool for all stakeholders to gain confidence in the introduction of nanotechnologies on the market. Industry provided key input and presented a number of applications that were then discussed. The event explored best practices in communication, public engagement, and corporate responsibility for nanotechnologies in textiles. A follow up is foreseen.

Hearing on the Fluoridation of drinking water Fluoride is an element which has found wide application as a tooth decay preventing agent in toothpaste and oral care products. Because of its efficiency in preventing tooth decay, it has also been added to drinking water, salt and drinks as another way to prevent caries. Yet scientific evidence has also pointed to some potential negative health effects of fluoride when humans are exposed to high quantities. To obtain an up to date scientific view on the matter the European Commission asked the Scientific Committee on Health and Environmental Risks (SCHER) to elaborate an opinion on the safety of fluoride. As part of its efforts to provide a forum for societal actors to contribute to the scientific debate on various matters of public interest, the SCHER and the European Commission organised a hearing on its preliminary opinion on 17 September 2010 in Brussels. The aim of the hearing was to complement the internet consultation and provide stakeholders and the public with an opportunity to present scientific evidence and arguments to the SCHER Working Group on the opinion.

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Workshop on Computational Toxicology Assessing the potential risks of chemicals to human health and the environment is the cornerstone of the European Commission’s science-based policy making on chemicals. This calls for constant monitoring of scientific developments and incorporating them appropriately in the risk assessment process. EU citizens must have confidence that the Commission’s policies on health and on the environment are based on state of the art methodologies. As part of this process, the Risk Assessment Unit of DG SANCO organised on 30 September – 1 October 2010 a workshop in Brussels on computational toxicology. This novel area of science uses computer models, chemical structures, and data bases to allow scientists to simulate the toxicity profiles of chemicals based on their similarities to others with known safety pedigrees. A total of 40 participants from the Commission, the EU Scientific Agencies and Bodies as well as the computational developers and users participated. Several modelling and computational models were demonstrated and discussed. Participants felt that computational models are an excellent tool in an integrated, weight of evidence approach in risk assessment and identified a number of areas for further research and refinement to improve their utility.

Chairs and Vice-Chairs meeting, Copenhagen The 6th meeting of Chairs and secretariats of EU Commission and Agency Scientific Committees and Panels, co-ordinated by DG SANCO, took place on 11 and 12 November 2010 at the EEA in Copenhagen. It was well attended by Chairs and staff from EFSA, ECHA, EEA, EMEA, ECDC, SCCS, SCHER, SCENIHR and SCOEL. The meeting was organised by the European Environmental Agency (EEA) and DG SANCO It was devoted to discussion of a few concrete issues which are currently addressed by one or more Committees/Agencies or are part of collaborative projects launched as follow up to previous Chairs’ meetings and international dialogue events. The meeting focused on the assessment of chemical mixtures, the use of “thresholds of toxicological concern” (TTC), and how to ensure transparency and the appropriate terminology in communicating uncertainties.

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Risk assessment

Risk assessment

Opinions of the European Commission Scientific Committees

Other publications/Communication activities

This has been another productive year for the European Commission Scientific Committees. Overall, 53 opinions were adopted in 2010 by the three non-food Scientific Committees on a wide variety of subjects such as cosmetics, chemicals in toys, mercury in energy saving light bulbs, lead in jewellery, depleted uranium, medical devices, tobacco additives and nanomaterials: These have been or are being used as the basis for policy making by the European Commission in order to ensure a high level of health protection for European citizens and the environment. The opinions can be found at the following webpages:

Several articles were published by staff of C7 on the role of the Scientific Committees (Kilian K, Bromen K. Verbrauchersicherheit, öffentliche Gesundheit und Umwelt - Wissenschaftliche Beratung auf europäischer Ebene. Bundesgesundheitsblatt 2010; 53:528–533. Bromen K. Assessing health risks in Europe: The Scientific Committees of the European Union. European Journal of Public Health, 2010; 20(6):716–717) and on Nanotechnologies (Garkov V, Bontoux L, Martin P – Into the Unknown. Public Service Review: European Union: Issue 19: 417-420.)

SCENIHR: http://ec.europa.eu/health/scientific_committees/emerging/opinions/index_en.htm SCHER: http://ec.europa.eu/health/scientific_committees/environmental_risks/opinions/index_ en.htm

More information: http://ec.europa.eu/health/scientific_committees/publications/index_en.htm Two Newsletters are published on the work of the Scientific Committees (see http://ec.europa. eu/health/scientific_committees/newsletters/index_en.htm) and the Annual Compendium on all the opinions published within a year.

SCCS http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/index_en.htm

Plain language versions of the Scientific Opinions As in the past, several of the Committees’ opinions are published as plain language versions to make it easier for a non-specialist audience to read and understand the opinions. Due to the start of the current Scientific Committees in March 2009 and the subsequent time-lag in delivering opinions, no laymen-versions were published in 2010 but are in the process of being produced. More information: http://ec.europa.eu/health/scientific_committees/policy/opinions_plain_language/index_ en.htm

Promoting Healthy Environments with a focus on the impact of actions on Electromagnetic Fields, August 2010 The purpose of this study, performed under the frame of the first EU Environment & Health Action Plan (2004-2010), was to analyze the actual exposure of the general public to EMF in the EU, to assess the actions taken at EU level since 2004 and to identify measures that could be taken to reduce the exposure of the general public if needed and estimate their costs. More information: http://ec.europa.eu/health/electromagnetic_fields/docs/bio_frep_en.pdf

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Fostering good health

Social Determinants of Health and Health Inequalities The vision of the Commission is for a fair distribution of health as part of overall social and economic development. The need to reduce health inequalities is therefore included in the Europe2020 strategy. Achieving this vision requires action on the social, environmental and behavioural causes of ill health as well as on prevention and treatment. This has to take place at EU, national and local levels. During 2010, SANCO concentrated on building support for action by working with partners, helping develop tools, improving wording for policy makers and identifying and disseminating examples of good practice. Key results were: • The Council produced Conclusions on equity in health in June 2010 supporting the Commission’s actions and encouraging Member States and the Commission to carry out further work. • The Committee of the Regions made health inequalities one of its priorities for a new technical platform on health. This encourages the sharing of information and good practice between regions. • Parliament began an initiative on health inequalities expected to be adopted in 2011.


• The Roma Summit in April 2010 had a major focus on health inequalities amongst Roma. This issue is being addressed through the Commission’s Roma Task Force (RTF) which will report on future actions in Spring 2011. • 15 Countries led by the UK started a “joint action” funded through the Health Programme to implement elements of the health inequalities communication - including regional and scientific networks, stakeholder initiatives and work on health inequality impact assessment and audit. • The PROGRESS programme (DG EMPL) selected 6 projects on health inequalities for funding for support • The EU research programme allocated EUR 3m for research on health inequalities. • Publications and workshops took place to provide help with getting funding from the EU structural funds for action on health inequalities. • Joint work took place with the World Health Organization on a review of the European health divide.

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These and other actions are leading to increased commitment and increased action by the EU, and by Member States, regions and stakeholders to reduce health inequalities in Europe. Details can be found in the database of the Determine project funded under the EU health programme.

and restaurants) in January 2010 and September 2010, respectively, although enforcement remains a problem. A similar ban came into force in Spain in January 2011. Smoke-free provisions have also been strengthened in Belgium (January 2010), Poland (November 2010) and Bulgaria (December 2010), albeit falling short of a total ban on smoking.

See the videos at http://ec.europa.eu/health/social_determinants/videos/index_en.htm

International Tobacco Control

Read more on SANCO health inequalities pages. http://ec.europa.eu/health/social_determinants/policy/index_en.htm

The Commission contributed actively to the preparation and successful outcomes of the fourth Conference of the Parties (COP) to the Framework Convention on Tobacco Control (FCTC) in November 2010, in Uruguay.

Determine database of actions: http://www.health-inequalities.org/

Tobacco Control Tobacco Products Directive The process of reviewing the Tobacco Products Directive continued during 2010 with a public consultation asking for comments/opinions on options for change. The consultation triggered much interest and many responses. A second round of stakeholder discussions took place in October 2010 on the basis of a study prepared by RAND Europe. Both elements of consultation will contribute to the Impact Assessment which the Commission is currently preparing. A Commission report on the implementation by Sweden of the measures necessary to ensure that oral tobacco is not placed on the market in other Member States was published in July 2010. Smoke-free environments A Council Recommendation on smoke-free environments is in force since November 2009. A number of Member States strengthened their smoke-free provisions in 2010. Cyprus and Greece introduced smoke-free legislation without exceptions in public places (including bars

This included in particular the adoption of (partial) guidelines on product regulation and disclosure for ingredients which increase the attractiveness of tobacco products, where the Commission acted as a Key Facilitator. The Commission was also actively involved in the decision of the COP to continue the process for a protocol on illicit trade in tobacco products and to extend the mandate of the existing International Negotiation Body on illicit trade in tobacco products to a fifth session. This session will be held early 2012 in Geneva and be preceded by two working Groups. More information: http://www.who.int/fctc/en Help campaign During 2010 the second edition of the media campaign “HELP – For a life without tobacco continued in the 27 EU countries. This campaign aims to prevent tobacco take-up, encourage cessation and inform about the dangers of passive smoking. Help 2.0 was an integrated campaign including television, the internet and new media such as mini-sites accessible through mobile phones. The whole campaign was “web driven”, the objective was to draw young people to the Help website (www.help-eu.com) where all the information on the dangers of smoking as well as the links to partner organisations are to be found. The website is available in 22 languages and the web and media campaign will be complemented by a series of European and national public and press relations events.

1 Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products. OJ L 194, 18.7.2001, p. 26–35. 2 Council Recommendation of 30 November 2009 on smoke-free environments (2009/C 296/02), OJEU C 296, 5.12.2009, p. 4–14.

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A call for tender for the continuation of the anti-tobacco campaign was launched in 2010. More information: http://ec.europa.eu/health/tobacco/policy/index_en.htm

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Nutrition and physical activity The EU Platform for Action on Diet, Physical Activity and Health has so far delivered close to 300 commitments and celebrated five years of active work in 2010. The first external evaluation report of the EU platform was published in July 2010. Among its conclusions was that self-regulation commitments in the areas of advertising and marketing to children and food/drink reformulation are having an impact, although this impact could be further strengthened. More at: http://ec.europa.eu/health/nutrition_ physical_activity/platform/index_en.htm The evaluation report can be found here: http://ec.europa.eu/health/nutrition_physical_activity/docs/evaluation_frep_en.pdf The High Level Group on Nutrition and Physical Activity This group is comprised of representatives from all Member States governments and ensures the rapid sharing of knowledge and good practices as well as the coordination of national initiatives in key fields such as product reformulation. In 2010, the High Level Group discussed health inequalities, food reformulation and monitoring of the implementation of Member States’ strategies for nutrition and physical activity. One of the first priorities of cooperation for this Group was to establish an EU framework on salt reduction. At the EPSCO of June 2010, the EU Health ministers adopted Council Conclusions calling Member States to pursue efforts in implementing salt reduction campaigns.

Fostering good health More at: http://ec.europa.eu/health/nutrition_physical_activity/high_level_group/index_en.htm The Council Conclusions on salt reduction can be found here: http://www.consilium.europa. eu/uedocs/cms_data/docs/pressdata/en/ lsa/114998.pdf The implementation progress report is published here: http://ec.europa.eu/health/nutrition_physical_activity/docs/implementation_ report_en.pdf High Level Conference on Monitoring and Evaluation of EU and Member States’ strategies on nutrition, physical activity, overweight and obesity related health issues Together with the Belgian Presidency of the European Council, the Commission organised a high level conference on 8-9 December 2010. The conference aimed to exchange experiences and views on the progress and the future of policies to help reduce overweight and obesity in the EU; to consolidate monitoring and evaluation processes. This conference brought together Member State delegations, the High Level Group on Nutrition and Physical Activity, WHO Monitoring National Focal Points and Nutrition Counterparts of the European Region, and the EU Platform for action on Diet, Physical Activity and Health - in total, 250 participants. A delegation from Canadian Health authorities also participated to this conference. Director General Paola Testori Coggi presented the mid-term Strategy progress report at the conference, while Commissioner Dalli presented the Commission’s view on the next three years of the Strategy implementation. More at: http://ec.europa.eu/health/nutrition_physical_activity/events/ev_20101208_en.htm

In December 2010, the first implementation progress report for the Strategy for Europe on Nutrition, Overweight and Obesity related health issues was published. This report took stock of progress made until now as regards EU Member States’ efforts and the actions implemented by the Commission and different stakeholders in seven general areas for action identified in the Strategy.

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Alcohol The EU alcohol strategy is designed to help national governments and other stakeholders coordinate their action to reduce alcohol related harm in the EU. The implementation of the strategy continued in 2010. • In 2010, the Member States Committee on National Alcohol Policy and Action (CNAPA) met twice, in January and September. Member States had the opportunity to share ap proaches and best practices on alcohol policy development. • The European Alcohol and Health Forum (EAHF) which engages wider stakeholders, such as NGOs and alcohol producer companies also met twice in March and November 2010. The Forum now has around 60 Members. Overall, 170 Commitments had been introduced by the Forum members at the end of 2010. • Progress in the implementation of the alcohol strategy was also discussed with a broader range of stakeholders in the 3rd Open Forum which took place on 19 November 2010. Work concentrated very much on prevention of alcohol and young people. The EAHF established a youth specific task force on alcohol which produced as result the RAYPRO database launched in 2010. RAYPRO is an online resource for sharing good practice projects focussed on alcohol and young people. • A major seminar on youth drinking and binge drinking took place February 2010. The seminar pointed out the need and potential of involving additional actors: parents, schools and health professionals. More information http://ec.europa.eu/health/alcohol/policy/index_en.htm

Environment and health: 5th Ministerial Conference on Environment & Health, Parma - 10-12 March 2010 About 950 participants registered for the conference. Delegates from 53 countries of the WHO European Region participated. The Conference had a quite high political participation with some 27 Ministers (health and/or environment) Deputy Ministers and Secretaries of State. The Commission delegation was lead by Commissioner Dalli and included, for the first time, two youth delegates, from Malta and Hungary. The European Environment Agency (EEA), the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) were also present with their own delegations. The conference endorsed the Parma Ministerial Declaration (1). This Declaration brings new priorities in the environment and health process namely:

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• • • • • •

Tackling the health and environmental impact of climate change; Addressing socioeconomic inequities in human environment and health Reducing the health risks to vulnerable population groups posed by poor environmental conditions (this concerns children, elderly or people already suffering from pre-existing chronic diseases and conditions). Working on chemicals to reduce the risks posed by persistent and bio-accumulating compounds Preventing diseases by improving outdoor and indoor air quality Addressing obesity and injuries through safe and healthy environments and increasing physical activity

The European Commission issued a Declaration of Support to the Parma Ministerial Declaration which was handed over by Commissioner Dalli to the WHO Regional Director, Zsuzsanna Jakab during the signing ceremony. The Conference drove Europe’s agenda on emerging environmental health challenges for the years to come. Commission is ensuring that synergies between EU level actions and those arising from the Parma Conference are fully exploited. The Declaration will continue to provide the youth perspective and ideas on environment and health issues in Europe. More (1) (2) (3) (4)

information: http://www.euro.who.int/__data/assets/pdf_file/0011/78608/E93618.pdf http://ec.europa.eu/health/healthy_environments/docs/parma_declaration_en.pdf http://ec.europa.eu/health/healthy_environments/docs/env_en.pdf http://ec.europa.eu/health/healthy_environments/events/parma_en.htm

Preventing injuries in Europe European Parliament (EP) debate - 17 March 2010 At the EP premises, the WHO presented their report on the implementation of both the 2007 Council Recommendation and the WHO Resolution on injury prevention prepared in the framework of their dissemination package included in their contract 2006/WHO/02 funded by the Commission. This report was launched and distributed during the Parma event. WHO reported on the progress made in Europe in preventing injuries, from international collaboration to local implementation, and underlined that 800.000 deaths occur per year in Europe due to injuries (leading cause of death for 5-44 year olds), and inequalities between and among countries as well as alcohol/socio economic factors as risk factors for injuries/violence. The Commission focused on cross-cutting issues related to injuries such as road safety (transport), health and safety at work (employment), product safety (consumer protection) and key health determinants (health), bringing the perspectives of healthy environments and making the link to Parma 5th Ministerial Conference Declaration regarding environment & health. The Czech Republic, Finland and Belgium presented their respective national situation and actions in this field. NGOs such as Eurosafe – European Child Safety Alliance and YOURS - youth NGO focusing on road safety – and child accident prevention trust (UK) also participated. A debate on the best solutions to this problem took place. It was encouraging to see that certain Member States have set up national plans regarding injury prevention, which will feed the Commission evaluation exercise foreseen by the 2007 Council recommendation on the prevention of injury and promotion of safety. Parliament Magazine’s event report, as well as speaker PowerPoint presentations, available via: http://www.theparliament.com/preventinginjuries To view the event photos: http://www.jylimet.com/theparliament/10-03-17/

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Health Information and Communication

Health reports The Women’s Health Report was published in January 2010, presenting an overview of the state of women’s health in the European Union. The report focuses on women aged 15 years and older in the 27 EU-Member States, as well as the EEA countries Norway, Iceland, and Liechtenstein, and occasionally Switzerland. More information: http://ec.europa.eu/health/population_groups/docs/women_report_en.pdf OECD report The “Health at a Glance: Europe 2010” report, jointly published by the European Commission and the OECD, compiles data from the OECD, Eurostat and the WHO. The report presents key trends on health, health systems and health spending in the 27 EU Member States, plus the 3 European Free Trade Association countries (Iceland, Norway and Switzerland) and Turkey. More information: http://ec.europa.eu/health/reports/european/health_glance_2010_en.htm

Heidi


In October 2010, SANCO presented the test (beta) version of the Heidi wiki. Heidi (Health in Europe: Information and Data Interface) is an internet based wiki tool for European health information and data. Heidi’s aim is to be the one-stop-shop for health information by containing up-to-date and referenced data, indicators, analysis, reports, links, references, bibliography on a broad coverage of topics. It will provide European added-value by becoming a single central health information reference for the EU. Heidi provides a tool for sharing, comparing and developing information across Europe. As a dynamic platform, Heidi enables users to correct or adjust existing information quickly and give feedback on its usefulness. In concrete terms, readers will be able to use the wiki as a kind of ‘living report’ on health in the EU. Ultimately, by providing comparable and up-to-date data, Heidi can help develop evidence-based policies to improve the health of Europeans. Heidi was first presented to the public in the European Health Forum in Bad Gastein, Austria (October 2010) and in the EUPHA-ASPHER conference (November 2010). Feedback received in these events is available in the Heidi. The initial content in Heidi wiki is based on the work of two projects co-financed by the Health Programme: the EUPHIX, and the Eugloreh – “The Report on the Status of Health in the European Union”. Heidi is still work in progress – the technical system is ready but the content needs to be restructured and made more user-friendly. During the test phase, SANCO would like to hear feedback and suggestions about Heidi’s navigation, usefulness or topics covered. A question about health in Europe? Heidi can help you! An answer about health in Europe? You can help Heidi! http://ec.europa.eu/health/heidi

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Heidi data tool The Heidi data tool is an interactive application to present relevant and comparable information on health at European level. The tool is presenting a list of indicators, grouped in four sections: • demographic and socio-economic factors, • health status, • determinants of health, • health interventions: health services.

Health Information and Communication • Tobacco, Special Eurobarometer 332, May 2010; • Organ donation and transplantation, Special Eurobarometer 333a, June 2010; • Blood donation and transfusions, Special Eurobarometer 333b, June 2010. In parallel, in 2010 the Commission launched other Eurobarometer surveys whose results are already published or will be published in 2011 for following topics: • Electromagnetic fields, Special Eurobarometer 347, June 2010; • Mental health, Special Eurobarometer 345, October 2010; • Rare diseases.

Besides browsing among all European Health Indicators (EUHI), users can limit their analysis to the European Community Health Indicators (ECHI) and view each indicator as a line graph, a bar chart, a map, a table, a html page or an image.

More information: http://ec.europa.eu/health/eurobarometers/index_en.htm

*Health in Europe: Information and Data Interface

Public Health website revamping

More information: http://ec.europa.eu/health/indicators/indicators/index_en.htm

Directorate C has recently concluded the revamping exercise of the Public Health website, which took more than two years and was carried out entirely with internal resources. This can be considered as a success story, both in terms of results achieved and lessons learnt. All the linguistic versions are now on line. Citizens can be informed about what the Commission does for the health policy; through accurate, comprehensive and up-to-date information that is easy to find and organised in a thematic way. Since a new unit responsible for Pharmaceuticals issues joined Directorate C, web site pages concerning Medicinal products for human use, Medicinal products for veterinary use, International activities were integrated in the public health web-site were integrated into the Public Health web site. The new website is now in 13th place on the EUROPA websites ranking. More at: http://ec.europa.eu/health/index_en.htm

Surveys In 2010, the Commission published the following Eurobarometer surveys (carried out in 2009) in the area of public health: • Oral health, Special Eurobarometer 330, February 2010; • Influenza H1N1, Flash Eurobarometer 287, March 2010; • Antimicrobial resistance, Special Eurobarometer 338, April 2010; • Patient safety and quality of healthcare, Special Eurobarometer 327, April 2010; • EU citizens’ attitudes towards alcohol, Special Eurobarometer 331, April 2010;

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Health Crisis Communication website A crisis communication website was developed in 2010 in order to improve risk management systems for Directorate C. The website is activated in case of health crisis or alert, informing about policy/activities carried out by the Commission, providing official documents, statements, guidelines issued from the EU and the Member States, epidemiological data and statistics, linking to all the relevant actors involved in the crisis management (EU Agencies, International Organisations, Member State competent authorities). The website was launched on 18 January 2011 as 2010-2011 seasonal flu website. More at: http://ec.europa.eu/health/flu_2011/index_en.htm

Health-EU e-newsletter Complementing the wealth of information on the portal itself, the e-newsletter provides twice a month with a selection of the latest news and activities in the field of public health at both European and international level. In 2010 subscribers number grew up to 9500. These were the editions brought out in 2010 December 2010 ________________________________________ Issue 61 (21-12-2010) : EU Health Prize for Journalists 2010 Issue 60 (09-12-2010) : Nutrition, overweight and obesity-related health issues November 2010 ________________________________________ Issue 59 (25-11-2010) : Nanomaterials: challenges for risk assessment Issue 58 (12-11-2010) : High-level conference on dementia (Brussels, 25-26 November 2010) October 2010 ________________________________________ Issue 57 (28-10-2010) : EU Health Programme: a key tool for health Issue 56 (14-10-2010) : Become a donor - save a life - Organ donation day September 2010 ________________________________________ Issue 55 (23-09-2010) : International Day of the Elderly (1 October 2010) Issue 54 (09-09-2010) : Investing in Europe’s health workforce of tomorrow July 2010 ________________________________________ Issue 53 (01-07-2010) : Travel and Health – stay healthy…even on holiday! June 2010 ________________________________________ Issue 52 (14-06-2010) : World Blood Donor Day 2010 Issue 51 (03-06-2010) : Global Health: Your health – wherever you live May 2010 ________________________________________ Issue 50 (20-05-2010) : World Multiple Sclerosis Day - 26 May 2010

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April 2010 ________________________________________ Issue 49 (22-04-2010) : Tackling health inequalities Issue 48 (15-04-2010) : European Patients’ Rights Day (18 April 2010)

The EXPO took place between 1st May and 31st October in Shanghai, on the theme “Better city, better life”.

March 2010 ________________________________________ Issue 47 (24-03-2010) : World Tuberculosis Day 2010 Issue 46 (10-03-2010) : Fifth Ministerial Conference on Environment and Health February 2010 ________________________________________ Issue 45 (25-02-2010) : Rare diseases day 2010: “Bridging Patients and Researchers”

The EU set up a pavilion together with Belgium, which took over the EU’s rotating presidency in the second half of the year. Almost 75 million people visited the EXPO, of these some 6 million visited the EU pavilion, which was based on the theme “Intelligent Europe” and the sub-themes “Open Europe”, “Green Europe” and “Living Europe”. DG SANCO took part in some thematic events to raise awareness on many key topics such as healthy cities, food safety, and research into a healthy life. SANCO C Directorate visited China in June meeting with Chinese officials and organising two events:

January 2010 ________________________________________ Issue 44 (26-01-2010) : World Cancer Day (4 February 2010)

Media achievements Activity

2009

2010

Press Releases

24

13

Memos

16

6

Midday Express

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11

E-news

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Articles, interviews & editorials

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The biggest media events of 2010 were: Tobacco - A press conference to mark World No Tobacco Day and to announce the new clips from the HELP 2.0 campaign; - The launch of the revision of the Tobacco Products Directive and the on-line public consultation. The 2nd EU Health Prize for journalists Organisation of an EU-wide health journalism competition, a media seminar and an award ceremony in Brussels. The OECD/European Commission “Health at a Glance” Report, press release - together with a technical briefing in the Press Room - generated much media coverage. Line to take and responses to Journalists’ questions per topic • Health Threats: 52 • Pharmaceuticals: 30 • Tobacco, blood and tissues, organs: 27 • Health determinants and chronic diseases: 17 • Cross-border healthcare, patient safety, health workforce, innovation: 14 • Scientific Opinions: 10 • Reports and health data: 6 • Funding: 2 • Other: 3 • TOTAL: 161

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Shanghai Expo 2010

• Healthy cities Conference This was a unique opportunity to look at how public authorities can shape health policies in big cities in order to improve the well-being of their populations. Vice mayors in charge of health of major European and Asian cities shared their knowledge and experience on a range of key issues such as socio-economic inequalities in health, the ageing of the population, lifestyle issues in urban areas.The conference was opened by Commissioner for Health and Consumer Policy, Mr John Dalli. • A co-organised health forum at Chino European Internation Busineess School on best health practises: 6th Annual China Health Care Forum: Commissioner Dalli was present at the dinner and Andrzej Rys participated to the forum. A series of the cartoons “Helpers” and posters part of the anti-tobacco campaign managed by Public Health and Risk assessment Directorate, were shown in the EU Pavillon and conference, with great success. The home page of the Health-EU Portal and the entry texts of all topics has been translated in Chinese for Shanghai Expo 2010. As these pages don’t need updates and is a gateway for - potentially - millions of Chinese people, the EC has decided to keep it for some time.

Conferences In 2010, the Public Health and Risk Assessment Directorate organised 3 conferences, and participated in 17 conferences or events, by either sending speakers or by setting up an information stand with publications. Main events were: • • • • • • • • • • •

WHO Fifth Ministerial Conference on Environment and Health, Parma, Italy 10 – 12 March Relai pour la Vie, Luxembourg, 13 March Medetel, Luxembourg, 14-16 April Open Health Forum, Brussels, 29-30 April 5th European Conference on Rare diseases conference, 13-15 May 2010, Krakow, Poland Global Health Conference, Brussels 10-11 June Mental Health of Older People, 28-29 June 2010, Madrid, Spain Belgian Presidency conference on the Pandemic H1N1 evaluation 1-2 July European Health Forum Gastein, 6-9 October EUPHA / ASPHER, Amsterdam, 10-13 November Mental Health Combating Stigma and Social Exclusion, 15-16 November, Lisbon, Portugal

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Publications In 2010, the Public Health and Risk Assessment Directorate prepared 37 posters, 21 brochures, 77 leaflets and several visuals for stands and logos. The EU Health strategy 2008-2013 has three objectives: • fostering good health in an ageing Europe • protecting citizens from health threats • supporting dynamic health systems and new technologies

EUPHA / ASPHER, Amsterdam 10-13 November

Participation mechanisms

Relai pour la Vie, Luxembourg, 13 mars

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Participation mechanisms

Cooperation mechanisms at EU level • EU Council senior working party– advises the Commission and promotes increased co ordination among EU countries. • Selected Commission-led health committees and expert groups: - High-level group on nutrition and physical activity - HIV/AIDS think tank - European partnership for action against cancer - Health security committee - Patient safety and quality of care working group - Expert group on health information (Health information committee) - Working groups of former High-level Group on health services and medical care

Partnerships with interest groups Using structures such as the Health Forum, the Commission encourages all stakeholder groups, regional and local organisations to get involved in the development and implementation of actions to protect and improve the health of European citizens.

EU health forum The EU Health Forum is a means of informing and involving key health stakeholders in European health policy. It disseminates information, launches ideas for debate and contributes to policy building. It has 2 components: the EU health policy forum (52 non-governmental umbrella organisations) and the open forum. The Open Forum extends the work of the EU Health Policy Forum to a broader set of stakeholders in an annual flagship event. The idea is to provide a platform for networking and exchanging ideas, particularly for groups and organisations which are not normally part of the ‘EU circuit’. The fourth Open Health Forum conference took place on 29 and 30 June 2010 in Brussels with the overall theme “Together for Health – a Strategy for the EU 2020” with the main focus on the integration of health aspects in other policies within the overall EU 2020 strategy. The conference as well as the accompanying exhibition attracted over 550 participants coming from a huge range of stakeholder representations at EU, national and regional level.


More information at: http://ec.europa.eu/health/interest_groups/ eu_health_forum/open_forum/2010/index_ en.htm#fullwidth

Stakeholder dialogue group The Stakeholder Dialogue Group advises the Commission (Directorate General for Health and Consumers) on good practice in the consultation process.

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Global Health In 2010 DG SANCO has been a key actor in setting up a new EU policy framework to guide actions on global health. In March 2010, the Commission adopted a Communication on Global Health outlining four main approaches to improving global health: establish a more democratic and coordinated global governance; promote universal coverage and access to health services for all; ensure better coherence between EU internal and external policies relating to health; increase global health knowledge and boost access in developing countries to new knowledge and treatments. It was accompanied by three staff working papers prepared by DG Health and Consumers, DG Research and DG Development respectively. This followed a wide consultative process with stakeholders during the previous months. The Council adopted conclusions on this Communication in May 2010 and, on 10-11 June, DG Health and Consumers organised the first Global Health Conference with the presence of WHO Director-General Margaret Chan, African Union health and Social Affairs Commissioner Bience Gawanas, Ecuador Minister of Health David Chiriboga representing UNASUR, and many others. The objective of the Conference was to present the recently adopted Global Health policy framework and to discuss key challenges, goals, policy instruments and partnerships with stakeholders and global partners to see how the EU can most effectively engage with all actors to improve health at global level. In addition, a global health policy forum was instituted allowing Commission services, on a monthly basis to discuss current and emerging issues with Member States, international organisations and civil society – NGOs and industry, in a wide range of discussions on topics relevant to global health. These monthly meetings continue in 2011.

Bilateral relations Bilateral relations with several key strategic partners (the Russian Federation, China) were effectively maintained at diplomatic level - including through Commissioner’s visits to these countries - following the conclusion of cooperation agreements during the previous year. Discussions on health cooperation with other partners (e.g. USA, Switzerland) continued. Throughout 2010, DG SANCO conducted and concluded negotiations on the health chapters of major EU Partnership and Cooperation Agreements with third countries, including Moldova, Vietnam, Indonesia and the Philippines.

WHO Cooperation with the World Health Organisation is based on exchanges of letters concluded in 2010 which aimed to consolidate and intensify cooperation between the two organisations and identified a number of priority areas including health information, communicable diseases, tobacco control, environment and health, sustainable health development and research. This cooperation was particularly important during the coordination of efforts during the H1N1 influenza pandemic. In September 2010, Commissioner Dalli and the WHO Regional Director for Europe Zsuzsanna Jakab, made a joint declaration in Moscow setting out their vision on how the Commission and the WHO Regional Office for Europe could work better together in the future to promote the health of European citizens. This declaration covered health security, health information, innovation, health technology, health inequalities, investing on health and cooperation within countries. The Commission and the WHO Regional Office are now following this up operationally.

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International cooperation The growing international health presence of the Commission was also evidenced by fuller and more active participation than ever before at meetings of the WHO Governing Bodies (Executive Board meetings, the World Health Assembly and the annual meeting of the WHO Regional Committee for Europe). In addition, the Commission played important roles in the intergovernmental discussions on pandemic preparedness virus-sharing, on intellectual property and access to medicines, as well as in the Framework Convention on Tobacco Control – particularly at the Fourth Conference of the Parties meeting in November 2010 (see also under title International Tobacco Control) .

Enlargement Activities in the area of enlargement continued, with continuing dialogue, negotiation and assessments of the health acquis in candidate and potential countries. This contributed to both Iceland and Montenegro being granted EU candidate status. SANCO provided assistance to several TAIEX workshops that took place to familiarize enlargement countries with the EU health legislation and share best practices on implementation of the acquis. SANCO assisted several candidate countries and potential candidates benefiting from Pre-Accession Assistance that addresses particular reform needs aiming at proper implementation of the EU health acquis. More information at: http://ec.europa.eu/enlargement/the-policy/countries-on-the-road-to-membership/index_ en.htm

European neighbourhood and regional cooperation Within the framework of the European Neighbourhood Policy (ENP), DG Health and Consumers has intensified the health dialogue with neighbouring countries in several priority areas: health sector reform, health information and knowledge, communicable diseases surveillance and control, and health security, implementation of international health agreements. DG SANCO supported the progressive involvement of ENP partners in EU related health activities and in 2010, it invited neighbourhood countries to the HIV/AIDS Think Tank and the high-level global health event. In the context of last year’s Influenza A (H1N1) epidemic, DG SANCO has effectively established communication channels with additional ENP partners for the exchange of epidemiological information in the case of a public health emergency of international concern. DG SANCO continued to support and participate in meetings of regional health networks such as the Northern Dimension Partnership in Health and Social well-being or the South-eastern Europe Health Network in order to promote the EU public health agenda and share health policy solutions, experiences and responses at regional level. In 2010, regional health organisations were effectively consulted and involved in EU level policy initiatives such as the Global Health Communication or in the implementation of the EU Strategy for the Baltic Sea region and were invited to the June 2010 global health conference. More information at: http://ec.europa.eu/europeaid/where/neighbourhood/index_en.htm

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Working with EU Agencies

Health Committees 2011

(in line with EU Health Strategy 2008-2013) OBJECTIVE 1

OBJECTIVE 2

OBJECTIVE 3

FOSTERING GOOD HEALTH IN AGEING EUROPE

PROTECTING CITIZENS FROM HEALTH THREATS

SUPPORTING DYNAMIC HEALTH SYSTEMS

EAHC The Executive Agency for Health and Consumers (EAHC) implements the EU Health Programme, the Consumer Programme and the Better Training for Safer Food initiative.

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Nutrition and physical activity (High Level Group)

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Alcohol (Committee on National Alcohol Policy and Action)

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Tobacco Products Regulatory Committee, MS Expert Group on Tobacco Advertising, Scientific Tobacco Fund Committee

More information at: http://ec.europa.eu/eahc

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ECDC The European Centre for Disease Prevention and Control (ECDC) was established in 2005. It is an EU agency aimed at strengthening Europe’s defences against infectious diseases. It is seated in Stockholm, Sweden. More information at: http://ecdc.europa.eu/

HIV/AIDS Think Tank (Working group with MS)

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Injury Prevention (MS working group)

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Experts Working Group on Mental Health

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Consultative Group on Environment and Health (including MS Expert Group on Indoor Air Quality)

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The European Medicines Agency (EMA) is a decentralised body of the European Union, located in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. More information at: http://www.ema.europa.eu

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•

Section Public Health Preparedness

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Working Group EU Workforce for Health

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Working Group European Reference Networks

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Section Generic Preparedness

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Working Group Patient Safety and Quality of Care

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Section Influenza

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Committee on Cross-border Healthcare (forthcoming)

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Regulatory Committee on Tissues and Cells

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Regulatory Committee on Blood and Blood Components

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Regulatory Committee on Organs

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Human Substances Competent Authorities Group (combining competent authorities on blood & blood components, tissues & cells, on organs

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Action plan group on organs

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European Committee of Experts on Rare diseases

Network Committee (Decision 2119/98/EC) including the Early Warning and Response System Component of Network* International Health Regulation (IHR) Focal Points

*Two working groups of the Health Security Committee have been suppressed.

European Partnership for Action Against Cancer

HEALTH INFORMATION

EMA

Health Security Committee* -

Expert Group on Social Determinants and Health Inequalities

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Expert Group on Health Information replacing existing working groups in this area **

GLOBAL HEALTH •

International Health Experts Group

HORIZONTAL •

Health Programme Committee

** The Expert Group on Health Information replaced the Network of Competent Authorities, maintaining the following three sub-groups: WP Indicators, TF Health Expectancies and TF Health Examination Survey. The other groups have stopped meeting: Network of working party group leaders, WP Lifestyle, WP Mortality & Morbidity, WP Accidents& Injuries, WP Health System, WP Health & Environment, TF Major & Chronic Diseases, TF Rare Diseases.

SANCO Summer Party 2010 Luxembourg